Multipopulation Tailoring Clinical Trials: Design, Analysis, and Inference Considerations.

The article addresses the operating characteristics of multipopulation tailoring trials based on the conceptual decision framework of Brian Millen et al and relevant error rate control. Topics discussed include a review of issues and analysis principles of multipopulation tailoring trials, case studies illustrating application of decision principles and associated design considerations and practical implementation of multipopulation trial designs in the regulatory approval of new treatments.